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Androgen Receptor Antagonist

AZD5305 + Hormonal Therapy for Prostate Cancer (PETRANHA Trial)

Phase 1 & 2

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Candidate for treatment with enzalutamide, abiraterone acetate, or darolutamide with documented current evidence of metastatic prostate cancer.

For Part B: Patients must have mCSPC (de novo or recurrent) with a baseline PSA value of ≥ 0.2 ng/mL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6, 12, 18, 24 and 30 months

Awards & highlights

PETRANHA Trial Summary

This trialwill measure the safety, effectiveness, and how the body absorbs & responds to AZD5305 when combined with new treatments for metastatic prostate cancer.

Who is the study for?

Men over 18 with metastatic prostate cancer who are candidates for treatment with enzalutamide, abiraterone acetate, or darolutamide. They must be castrated (surgically or medically), have good organ and marrow function, an ECOG Performance Status of 0-1, a life expectancy of at least 16 weeks, and agree to use contraception if necessary. Not eligible if they've had certain prior treatments like PARP inhibitors in the mCSPC setting or strong CYP3A4 inducers.Check my eligibility

What is being tested?

The trial is testing AZD5305 combined with new hormonal agents (NHAs) such as enzalutamide, abiraterone acetate, or darolutamide in men with metastatic prostate cancer. It aims to assess safety and how well the body handles the drug combination while also looking at early signs of effectiveness.See study design

What are the potential side effects?

Possible side effects include typical reactions to hormone therapies like fatigue, digestive issues and potential changes in liver function tests. Since this is a study combining drugs there may be additional unknown risks.

PETRANHA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am eligible for specific prostate cancer treatments and my cancer has spread.

Select...

I have metastatic castration-sensitive prostate cancer with a PSA level of at least 0.2 ng/mL.

Select...

I have advanced prostate cancer that is resistant or sensitive to hormone therapy.

Select...

I have undergone treatment to lower my testosterone levels.

Select...

I am 18 years old or older.

Select...

My prostate cancer has spread and was confirmed by a biopsy.

Select...

I am fully active or have some restrictions but can still care for myself, with no worsening in the last 2 weeks.

PETRANHA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6, 12, 18, 24 and 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6, 12, 18, 24 and 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 12, 18, 24 and 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of patients with Adverse Events and Serious Adverse Events

Part A: Number of patients with Dose Limiting Toxicities (DLTs)

Secondary outcome measures

AUC of AZD5305

AUC of Apalutamide

AUC of Enzalutamide

+19 more

PETRANHA Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm 4 (AZD5305 in combination with apalutamide)Experimental Treatment1 Intervention

Patients will receive an oral dose of AZD5305 and Apalutamide once daily until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study treatment occur.

Group II: Arm 3 (AZD5305 in combination with darolutamide)Experimental Treatment2 Interventions

Patients will receive an oral dose of AZD5305 once daily and Darolutamide twice daily until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study treatment occur.

Group III: Arm 2 (AZD5305 in combination with abiraterone acetate)Experimental Treatment2 Interventions

Patients will receive an oral dose of AZD5305 and Abiraterone Acetate once daily until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study treatment occur.

Group IV: Arm 1 (AZD5305 in combination with enzalutamide)Experimental Treatment2 Interventions

Patients will receive an oral dose of AZD5305 and Enzalutamide once daily until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study treatment occur.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Apalutamide

2015

Completed Phase 2

~3310

Darolutamide

2018

Completed Phase 2

~100

Abiraterone Acetate

2015

Completed Phase 4

~1880

Enzalutamide

2014

Completed Phase 4

~2760

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

BayerIndustry Sponsor

2,240 Previous Clinical Trials

25,332,605 Total Patients Enrolled

39 Trials studying Prostate Cancer

25,919 Patients Enrolled for Prostate Cancer

AstraZenecaLead Sponsor

4,271 Previous Clinical Trials

288,612,687 Total Patients Enrolled

60 Trials studying Prostate Cancer

27,522 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone Acetate (Androgen Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05367440 — Phase 1 & 2

Prostate Cancer Clinical Trial 2023: Abiraterone Acetate Highlights & Side Effects. Trial Name: NCT05367440 — Phase 1 & 2

Abiraterone Acetate (Androgen Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05367440 — Phase 1 & 2

Prostate Cancer Research Study Groups: Arm 4 (AZD5305 in combination with apalutamide), Arm 3 (AZD5305 in combination with darolutamide), Arm 1 (AZD5305 in combination with enzalutamide), Arm 2 (AZD5305 in combination with abiraterone acetate)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the prime objective of this exploration?

"Throughout the extended duration of this trial (up to 2.3 years post-treatment) investigators will be evaluating the number of patients with dose limiting toxicities, as well as other secondary outcomes such as peak concentration and time to response when AZD5305 is administered in combination with NHA. Additionally, they are assessing percentage changes in tumour size for participants who present measurable disease at baseline."

Answered by AI

Does this trial accept participants younger than 35 years old?

"Patients of any age from 18 to 130 are eligible for participation in this study."

Answered by AI

Are there vacancies in this experimental protocol for individuals?

"Indeed, clinicaltrials.gov reports that this medical investigation is presently recruiting participants. It was first listed on June 2nd 2022 and has since been updated as of December 6th 2022. A total of 72 people are needed to be recruited from 4 different locations."

Answered by AI

Do I qualify to be part of this medical research endeavor?

"Patients that meet the criteria of having a malignant neoplasm and being between 18 to 130 years old may be accepted into this trial, with 72 individuals sought in total."

Answered by AI

Could you provide a tally of the current locations where this experiment is being conducted?

"This clinical trial is currently happening at 4 sites, situated in Detroit, San Diego, Syracuse and other cities. To minimize the amount of travelling if you decide to take part, it is best to select a centre that is closest to your location."

Answered by AI

How many people are taking part in this clinical experiment?

"Absolutely. According to the information present on clinicaltrials.gov, this medical experiment is actively recruiting participants, with an original posting date of June 2nd 2022 and a recent update dated December 6th 2022. A total of 72 patients are being recruited from 4 different sites for the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer

2022. "Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05367440.

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